NCT06651086

Brief Summary

This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
672

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Dec 2024Aug 2029

First Submitted

Initial submission to the registry

October 9, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

October 9, 2024

Last Update Submit

April 15, 2026

Conditions

Autism Spectrum DisorderExecutive Functioning

Keywords

Autism spectrum disorderexecutive functioningemotion regulationmental health symptomsUnified Protcol for ChildrenUnstuck and On Targetevidence based intervention

Outcome Measures

Primary Outcomes (4)

  • Changes in Child Mental Health Symptoms

    Changes in mental health symptoms will be measured by the Child Behavior Checklist (CBCL), a 113-item rating scale measuring a range of mental health symptoms.

    Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

  • Externalizing Behaviors

    Primary outcome measures include externalizing behaviors. The Eyberg Child Behavior Inventory (ECBI), a 36-item widely used rating scale, will measure these behaviors.

    Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

  • Evidence-based Intervention Fidelity

    A trained observer masked to evidence-based intervention (EBI) condition and time will assess EBI delivery during recorded sessions of participating therapist-client dyads. Unique fidelity forms with items corresponding to each EBI (Unstuck and On Target and Unified Protocol for Children) will be used. Items rate adherence (i.e., the degree to which key components are delivered as intended) and competence (responsiveness, engagement, skill). Items are rated on a 1-5 scale, with higher scores indicating better fidelity. Measures have internal consistencies and are shown to be sensitive to treatment effects.

    During 6-month EBI implementation

  • Evidence-Based Intervention Training Engagement

    Therapist evidence-based intervention (EBI) training engagement will be operationalized as adherence to training requirements, including participation in training/consultation (as rated by trainers) and training-related submissions (forms, materials).

    6-months post-EBI implementation

Secondary Outcomes (2)

  • Evidence-Based Intervention Reach

    6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation

  • Psychotherapy Quality

    6-months post-EBI implementation

Other Outcomes (8)

  • Clinical Mediator: Changes in Executive Functioning, BRIEF-II

    Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

  • Clinical Mediator: Changes in Executive Functioning, EFCT

    Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

  • Clinical Mediator: Changes in Executive Functioning, DCCS

    Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

  • +5 more other outcomes

Study Arms (2)

Unstuck and On Target

ACTIVE COMPARATOR

Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.

Behavioral: Unstuck and On Target

Unified Protocol for Children

ACTIVE COMPARATOR

Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).

Behavioral: Unified Protocol for Children

Interventions

Unstuck and On TargetBEHAVIORAL

Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.

Unstuck and On Target
Unified Protocol for ChildrenBEHAVIORAL

Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).

Unified Protocol for Children

Eligibility Criteria

Age6 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mental Health Programs:
  • Publicly-funded
  • Providing outpatient or school-based psychotherapy services to children
  • Have at least 8 mental health providers on staff
  • Therapists:
  • Employed as staff or trainee at a participating program
  • Employed at the program for at least the next 12 months
  • Providing psychotherapy services to children
  • Has an eligible child on current caseload (see below)
  • Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):
  • Child age 6-12 years
  • Receiving services from an enrolled therapist
  • Documented or suspected\* autism diagnosis
  • In the event of suspected autism diagnosis, the presence of elevated autism symptoms on the Social Responsiveness Scale-2nd Edition or the Autism Diagnostic Observation Scale-2nd Edition
  • Non-Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

University of Colorado - Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (3)

  • Dickson KS, Galligan M, Holt T, Kenworthy L, Anthony L, Roesch S, Brookman-Frazee L. Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings. J Autism Dev Disord. 2025 Jul;55(7):2407-2421. doi: 10.1007/s10803-024-06365-8. Epub 2024 Apr 28.

    PMID: 38678517BACKGROUND

  • Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.

    PMID: 32699642BACKGROUND

  • Dickson KS, Kennedy SM, Safer J, Brookman-Frazee L, Roesch S, Anthony LG. Study protocol for a hybrid type 2 effectiveness-implementation trial of two interventions for autistic and non-autistic youth in children's mental health settings: one tailored for neurodivergence and one universal. Implement Sci Commun. 2025 Nov 26;6(1):131. doi: 10.1186/s43058-025-00799-6.

    PMID: 41299783DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Central Study Contacts

Kelsey S Dickson, PhD

CONTACT

858-966-7703kdickson@sdsu.edu

Hannah E Reynolds, MPH

CONTACT

hreynolds@sdsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Observational Coders Direct Assessor
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participating mental health programs from California and Colorado will be randomized to one of two conditions: Unstuck and On Target training and Unified Protocol for Children training. Therapists will be recruited from each participating program and enrolled as a dyad with target children. Autistic children will be enrolled at the beginning of therapist participation and before intervention training. Non-autistic children will be enrolled after intervention training and implementation or approximately 6 months after therapist enrollment. Participating therapists and child clients served in those programs will receive the same condition as their enrolled program.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 21, 2024

Study Start

December 15, 2024

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Deidentitifed data will be shared with NDA

Shared Documents
STUDY PROTOCOL
Time Frame
Will be reported per NDA timeline.
Access Criteria
Request login access to NDA

Locations

US(2)